Accelerator a3600 Automation System with the Aliquoter Module — Class II medical device recall Z-0433-2021
Terminated recall by Inpeco S.A., reported 2020-11-18. When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirat
| Recall number | Z-0433-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, Switzerland |
| Recall initiated | 2020-07-14 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2023-12-28 |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CL, CN, CO, DE, DZ, EG, ES, FI, FR, GB, HR, ID, IL, IT, MX, NL, PH, PT, QA, SA, SE, SG, TW, ZA |
| Quantity | 136 |
| Serial numbers | ACP.002, ACP.004, ACP.009, ACP.011, ACP.012, ACP.015, ACP.018, ACP.019, ACP.026, ACP.027, ACP.028, ACP.033, ACP.034, ACP.042, ACP.045, ACP.047, ACP.048, ACP.050, ACP.052, ACP.059, ACP.061, ACP.063, ACP.064, ACP.066, ACP.069 and 111 more |
| Model numbers | FLX-212 |
Product
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
Reason for recall
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0433-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.